NCT05177861

Brief Summary

Regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate the relationship between sleep quality disorder that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

January 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

December 13, 2021

Last Update Submit

April 27, 2022

Conditions

Ulnar Neuropathies

Outcome Measures

Primary Outcomes (1)

  • Pittsburg Sleep Quality Index

    sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.

    10 minutes.

Study Arms (1)

Electromyelography

OTHER

EMG will be performed only once to determine the ulnar nerve entrapment site in patients.

Diagnostic Test: EMG

Interventions

EMGDIAGNOSTIC_TEST

Electromyelography

Electromyelography

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
  • to be between the ages of 18-65
  • be give informed consent

You may not qualify if:

  • malignancy
  • surgical history in the ipsilateral upper extremity
  • sleep apnea
  • narcolepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, 65040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ulnar Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Volkan Şah

    Yüzüncü Yıl Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2021

First Posted

January 5, 2022

Study Start

January 22, 2022

Primary Completion

March 20, 2022

Study Completion

April 27, 2022

Last Updated

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)